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Article History

Received: 3 January 2018

Accepted: 5 June 2018

First Online: 10 July 2018

Ethics approval and consent to participate

: The ethics review committees at participating centers approved the study protocol (Additional file InternalRef removed). The study was conducted in accordance with Good Clinical Practice guidelines, and patients provided written informed consent prior to enrollment. All serious adverse events were reported to the Domain Specific Review Board and the Medical Clinical Research Committee, Ministry of Health in accordance with published guidelines. The study is registered at ExternalRef removed (Identifier: NCT00700895).

: Obtained as part of informed consent taking.

: The authors declare that they have no competing interests.

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